Operational Excellence Engineer

11865 S. Alameda Street
Lynwood, CA 90262, USA

• On-site
• Associate
• Full-Time
• Requisition #: OPERA
  002674

PL Developments, also known as PLD, is a leading manufacturer, packager, and distributor of over-the-counter (OTC) pharmaceutical products and consumer healthcare goods.

The Operational Excellence Engineer serves as the site's certified Lean Six Sigma Black Belt, leading complex, data-driven improvement projects that deliver measurable gains in yield, throughput, quality, cost, and service across OTC pharmaceutical manufacturing and packaging operations. Operating as a senior individual contributor within Operational Excellence, this role leads cross-functional DMAIC and Lean initiatives, applies advanced statistical analysis to solve chronic and high-impact problems, and builds continuous improvement capability by coaching Green Belts, Yellow Belts, and frontline teams.

The role also drives digital and data-enabled improvement, partnering with Technical Services and IT to define requirements, and applying GAMP 5 and FDA Computer Software Assurance principles to ensure systems and analytical tools used in GxP decision-making are appropriately validated. All improvements are executed in a cGMP-compliant manner, with changes to validated processes, systems, equipment, and documentation routed through Change Control and approved by Quality Assurance.

• Bachelor's degree in engineering (Industrial, Chemical, Mechanical, Pharmaceutical), Life Sciences, Statistics, or a related technical discipline required; advanced degree preferred
• Certified Lean Six Sigma Black Belt from a recognized body (ASQ, IASSC, or accredited corporate program) required;
  Master Black Belt certification or candidacy preferred
• Minimum 5–8 years of progressive experience in manufacturing, engineering, or operational excellence, including at least 3 years leading formal Lean Six Sigma projects
• Experience in OTC pharmaceutical, nutraceutical, food, or other FDA-regulated manufacturing strongly preferred; familiarity with solid dose, liquids, creams/ointments, or packaging operations preferred
• Strong working knowledge of FDA regulations and cGMP guidelines, including 21 CFR Parts 210/211 and OTC monograph requirements
• Demonstrated mastery of DMAIC, Lean tools (VSM, 5S, SMED, TPM, standard work, kanban, kaizen), and change management methodology
• Advanced proficiency in statistical analysis and software such as Minitab, JMP, or equivalent; capability studies, DOE, MSA/Gage R&R, hypothesis testing, regression, and SPC
• Working knowledge of OEE, capacity modeling, line balancing, and process cycle efficiency
• Working knowledge of change control, deviation/CAPA, validation, and risk assessment processes as they apply to process improvement
• Experience extracting and analyzing data from ERP, MES, LIMS, and historian systems; proficiency with Excel and data visualization tools such as Power BI or Tableau preferred
• Working knowledge of computer system validation principles, including ISPE GAMP 5 software categorization, FDA Computer Software Assurance (CSA) risk-based methodology, 21 CFR Part 11, and ALCOA+ data integrity expectations
• Experience defining user requirements, executing IQ/OQ/PQ or UAT test scripts, and supporting validation deliverables for systems or digital tools supporting manufacturing operations
• Familiarity with electronic batch records, automated data capture, and digital manufacturing/Industry 4.0 concepts preferred
• Proven ability to lead cross-functional teams without direct authority, influence at all organizational levels, and manage multiple concurrent projects
• Excellent written and verbal communication, facilitation, and executive presentation skills
• Strong financial acumen, including the ability to build and validate benefit cases with Finance

• Lead a portfolio of complex, cross-functional Black Belt projects from charter through control, delivering committed financial and operational benefits
• Apply the DMAIC methodology rigorously: define problem and scope, validate measurement systems, analyze root cause with statistical evidence, pilot and implement…